Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients

Ospedale di Circolo - Fondazione Macchi

Status and phase

Unknown

Phase 4

Conditions

Hyperlipidemia

HIV

HIV Infections

Treatments

Drug: ezetimibe

Drug: fenofibrate

Drug: pravastatin

Study type

Interventional

Funder types

Other

Industry

Identifiers

EFP01

Details and patient eligibility

About

The aim of the study is to compare the effects of coadministration of ezetimibe 10 mg/die + fenofibrate 200 mg/die versus pravastatin 40 mg/die monotherapy in HIV-infected patients treated with protease inhibitors.
Single-centre, open, randomized, controlled, prospective pilot study.
60 patients will be enrolled in order to reach the target of 50 patients evaluable at the end of the study. The patients will be randomly assigned to a 6-month treatment with ezetimibe+fenofibrate or with pravastatin.The visit will be every month.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

patients older than 18 years
documented positive HIV antibodies test
on stable therapy with PIs for at least 12 months
LDL-cholesterol >130 mg/dl or triglycerides 200 - 500 mg/dl with non-HDL cholesterol >160 mg/dl
unresponsive to dietary measures and regular physical exercise of at

Exclusion criteria

history of dyslipidemia before antiretroviral therapy
cardiovascular and cerebrovascular diseases
Cushing's syndrome
concurrent therapy with lipid-lowering agents, oral anticoagulant, estrogens, thiazidic diuretics, beta-blockers
hypothyroidism
Type 1 diabetes mellitus
renal failure